相关临床试验
3
1 进行中
药物批准
8
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
1
33.3%
已完成
1
33.3%
Unknown
1
33.3%
- Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. - Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos and Tuzemty, denosumab biosimilars referencing Prolia and Xgeva respectively. - Apotex's Denoza and Biocon's Bosaya and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field. - As of September 2026, Europe had approved 14 ustekinumab and 15 denosumab biosimilars, while the US had approved 8 and 19 respectively.
- Remedy Plan Therapeutics has initiated enrollment in Cohort 2 of its Phase 1 dose escalation trial of RPT1G in relapsed/refractory AML and higher-risk MDS. - The FDA has accepted an Investigational New Drug application for RPT1G in solid tumors, expanding the program beyond hematologic malignancies. - Cohort 1 patients completed the first full 28-day treatment cycle, which the company says marks the first sustained therapeutic NAMPT inhibition without limiting toxicity in cancer patients. - The company closed a Series A extension of approximately $30 million and appointed Oleg Zernovak, M.D. as Vice President, Clinical Development.
- A patient-level matched analysis of 587 urgent CABG patients found intraoperative CytoSorb use reduced BARC-4 severe bleeding by 37% (21.8% vs 34.5%; p=0.002). - The number needed to treat (NNT) to prevent one severe bleeding event was eight, consistent with the NNT of six seen in the randomized STAR-T trial. - Significant reductions in 24-hour chest tube drainage (p=0.039) and red blood cell transfusions (p=0.003) were observed, with no serious device-related adverse events. - CytoSorbents plans a new FDA De Novo submission for DrugSorb-ATR in early 2027, incorporating this real-world evidence under its Breakthrough Device designation.
- Researchers identified "Methylation Mesa" as functional regulatory elements that can be leveraged for targeted gene activation. - The work was supported by the National Research Foundation Singapore and Singapore Ministry of Education under its Research Centres of Excellence initiative. - The study involved collaborators from the Cancer Science Institute of Singapore and the Functional Genomics Consortium, including AbbVie, Bristol Myers Squibb, Janssen, Merck, and Vir Biotechnology. - The findings advance understanding of DNA methylation-based regulatory mechanisms with potential implications for epigenetic therapeutic strategies.
- WHO issued two medical product alerts in June–July 2026 for falsified JAKAVI (ruxolitinib) and DARZALEX (daratumumab) detected across Iran, Russia, Türkiye, Maldives, and Mexico. - Laboratory analysis of falsified JAKAVI 20 mg confirmed complete absence of the active ingredient ruxolitinib, while falsified DARZALEX vials contained visible particulate matter signaling contamination risk. - Both falsified products reached patients through online platforms and, in some cases, through pharmacies and hospitals, posing risks of treatment failure, disease progression, and death. - WHO urges healthcare professionals and regulators to increase supply chain surveillance, report adverse events, and immediately remove these falsified products from circulation.
- Elicera Therapeutics AB, a clinical-stage cell and gene therapy company, has appointed Johan Liwing as its new CEO effective September 1, 2026. - Liwing brings over 20 years of pharmaceutical and biotech experience spanning oncology, cell therapy, business development, and capital raising. - He previously served as CEO of Lipigon Pharmaceuticals and XNK Therapeutics, where he advanced programs to Phase 2 and established a GMP-certified cell therapy manufacturing facility. - Outgoing CEO Jamal El-Mosleh will remain with the company until October 31 to ensure an orderly leadership transition.
- A 56-year-old Tauranga woman with relapsed multiple myeloma is fundraising $200,000 for CAR T-cell therapy in Shanghai after exhausting all available treatment options in New Zealand. - The patient achieved a nine-year remission following initial chemotherapy and stem cell transplant but has since relapsed twice, with two subsequent cancer drugs proving ineffective. - The Malaghan Institute is conducting laboratory research on CAR T-cell therapy for myeloma but has no active myeloma trial, with future trials dependent on funding and experimental progress. - Pharmac has four funding applications for daratumumab under consideration, including three for multiple myeloma, but no timeline exists for a funding decision due to budget constraints.
- Two recent Nature portfolio publications highlight the growing role of machine learning and deep learning in predicting drug–target binding affinities and drug–drug interactions, addressing critical challenges in pharmaceutical R&D. - Sequence-based computational models are demonstrating improved accuracy in forecasting how drug compounds interact with biological targets, potentially accelerating early-stage drug discovery. - Deep learning frameworks for drug–drug interaction prediction offer new tools to identify adverse combination effects before clinical exposure, enhancing patient safety. - These computational approaches represent a shift toward data-driven, predictive pharmacology that may reduce reliance on costly and time-intensive experimental screening.
- RedHill Biopharma's RHB-204 demonstrated comparable MAP killing efficacy to RHB-104 in vitro testing, achieving similar antimicrobial activity with lower doses of two active ingredients. - The next-generation formulation offers potential for reduced toxicity and side effects while maintaining the therapeutic approach that showed 64% improvement over standard care in Phase 3 trials. - RHB-204's planned Phase 2 study will be the first clinical trial in a specifically defined MAP-positive Crohn's disease patient population, representing a potentially paradigm-changing treatment approach. - The Crohn's disease market is projected to grow from $13.6 billion in 2024 to over $19 billion by 2033, presenting significant commercial opportunity for novel therapies.
- Ligand Pharmaceuticals announced the acquisition of fellow biotech royalty aggregator XOMA Royalty for $739 million in cash, paying $39 per share with a 3% premium. - The deal adds more than 120 treatments to Ligand's portfolio, including seven marketed products such as Roche's Vabysmo, expanding the total portfolio to over 200 drugs. - Ligand raised its 2026 revenue outlook to $270-310 million and adjusted profit forecast to $8.50-9.50 per share, with the acquisition expected to be immediately accretive. - The company expects to earn $37.5 million annually at peak from royalties on eye drug Vabysmo and retains capacity to invest $150-250 million annually in additional royalty assets.
